SOURCES SOUGHT
A -- Preclinical Medications Screening in Dependence Models of Alcoholism
- Notice Date
- 12/18/2012
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NIAAA-SSN-2014-PNH
- Point of Contact
- Paul D McFarlane, Phone: 301-443-3041, Patty N. Hanacek, Phone: 301-594-6226
- E-Mail Address
-
pm24v@nih.gov, hanacekp@mail.nih.gov
(pm24v@nih.gov, hanacekp@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a Small Business Sources Sought Notice. THIS IS NOT A SOLICITATION FOR PROPOSALS, PROPOSAL ABSTRACTS, OR QUOTATIONS. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the planned acquisition. Responses to this notice, in the form of capability statements, will assist the Government in determining the appropriate acquisition method, including whether a small business set-aside is possible. ORGANIZATIONS THAT ARE NOT A SMALL BUSINESS UNDER NAICS CODE 541711 SHOULD NOT SUBMIT A RESPONSE. Background The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks a contractor to address the present and anticipated future needs of NIAAA's Medication Development Program. The Division of Neuroscience and Behavior's (DNB) Preclinical Medication Efficacy Testing Program seeks to re-compete a contract for the blind testing of reference compounds ( including those previously tested by NIAAA's Clinical Investigations Group (NCIG) program ) and proprietary compounds on alcohol drinking in mice using models of various aspects of alcohol dependence. The contract will use mechanisms having intellectual property conditions favorable to compound providers. This will eliminate a major barrier to testing optimized compounds having preclinical as well as clinical toxicology data and will stimulate interest by the pharmaceutical industry in developing high quality, marketable compounds for alcoholism. Overall, the contractor will assess effects of proprietary compounds in standardized models of alcohol dependence-induced alcohol intake using mice for subjects. The contractor will also develop and implement testing of proprietary compounds in additional mouse models, which may include drinking in the dark (DID), intermittent access drinking model, alcohol deprivation model (ADE), and conditioned place preference (CPP) models. The contractor will also collect, analyze and display data from these tests and report them to designated NIAAA personnel. The data generated by this contract will be used in the identification of compounds for further development. Project Requirements Compound Testing: On the basis of information provided by NIAAA, the Contractor shall test effects of compounds submitted to them by NIAAA staff members in voluntary limited-access 2 bottle choice drinking of unsweetened ethanol solutions in mice made dependent through repeated cycles of ethanol vapor exposure and withdrawal. If requested by NIAAA, contractor shall purchase reference compounds for testing. All details of experimental protocols shall be subject to the concurrence of the NIAAA Contracting Officer's Representative (COR). Minimally, testing protocols should conform to the following standards: a) Justification of sample size, including power calculation; b) blind testing; and c) random or stratified assignment of subjects to experimental conditions. The Contractor may be asked to evaluate whether the interventional drug reached and engaged the intended target when possible. Compound Storage and Administration: The Contractor shall store compounds supplied to them by NIAAA such that they cannot be readily accessed by personnel outside the Principle Investigator's laboratory. Adequate storage conditions, including minus 70 ° C freezers when noted, shall be available on site. The Contractor shall be responsible for providing all necessary reagents and supplies necessary for administering test medications according to instructions supplied by NIAAA. Ongoing Model Development and Validation: The Contractor shall further validate voluntary limited-access 2 bottle choice drinking paradigms in mice and additional alcohol consumption, reinforcement and reward paradigms as requested by NIAAA. This may include periodic tests with reference compounds designated by the NIAAA COR. These tests will be performed and reported upon completion. Data Analysis and Reporting: The Contractor shall perform appropriate statistical analysis of the data, and prepare a summary of the testing conditions and results including appropriate graphical displays. Reports shall also include interpretation of results written in language that can be understood by scientists not having specialized training in alcohol or addiction research. The report is to be submitted to the NIAAA COR (along with copies of raw data if requested), thirty (30) calendar days after the completion of the medication test. Data Recording: Throughout the life of the contract, the Contractor shall maintain a binder of all experimental protocols. Protocols shall be written using a strong scientific standard, with all details of the experiment recorded in such a way that another lab could replicate the study exactly. The binder shall contain all protocols proposed and/or tested during the duration of the contract, and shall include notations with regard to their current status. A copy of any protocol shall be available to the NIAAA COR upon request. Data Maintenance and Storage: The Contractor shall retain, for the duration of this contract, all laboratory notebooks (which shall include hard copies of raw data) and any electronic data files generated under this contract, as well as all coded proprietary test compounds received for evaluation under this contract. Electronic data files shall be labeled and recorded in a manner that allows their association with corresponding laboratory notebook entries and hard copies of raw data. On or before the expiration date of this contract, if so instructed by the NIAAA COR, the Contractor shall ship these items to the NIAAA COR. The Contractor shall not enter data from studies unrelated to this contract in notebooks or on disks containing data generated under this contract. Special Contract Requirements: While the Contractor will be free to publish data developed under this contract on compounds and materials (Materials) that are specified by the COR as publicly available, most of the Material provided to the Contractor will be proprietary to third parties. Data generated from testing and evaluation of these Materials will also be considered to be proprietary to the provider. Unless these data are protected, third parties are not likely to make their proprietary Materials available for testing and evaluation under the contract. Accordingly, the Contractor must agree not to publish data regarding proprietary test Materials unless the COR obtains permission from the provider. Additionally, in order to encourage third parties to submit their proprietary Materials for evaluation and testing, the Contractor must agree to offer the provider an option to an exclusive license to any subject invention conceived or first actually reduced to practice in the performance of work under this contract using a provider's proprietary Materials. Transition Plan: Within 150 calendar days of the contract's expiration date, the Contractor shall submit to the COR and the Contracting Officer (CO) a written draft transition plan outlining the following activities with dated milestones for completion of each. A final transition plan shall be agreed upon by the COR, CO, and Contractor within 45 calendar days of the draft's submission. The transition plan shall be written so as to accomplish all activities therein during the final 90 calendar days of the contract's period of performance (i.e. prior to the contract's expiration date). Status of any ongoing contract projects with anticipated completion dates Plan for transferring all contract-related electronic data to the NIAAA COR Plan for transferring all contract-related hard copy data (i.e. experimental protocols binders, etc. as described in the Data Analysis and Reporting and Data Recording elements of this statement of work) to the NIAAA COR Plan for final disposition of all contract Materials (i.e. Third Party Compounds and other Materials kept in minus 70 freezer(s) and in other storage locations to the NIAAA COR. Capability Statements Small business concerns that possess the capabilities necessary to undertake the aforementioned efforts should submit complete documentation of their capabilities to the Contracting Officer. This "capability statement" should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects in which the organization and proposed personnel have participated, 5) Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer's Representatives and Contracting Officers; and 6) any other information considered relevant to this program. The capability statement shall not exceed 10 single sided or 5 double sided pages in length and using a 12-point font size, minimum. Interested small business organizations are required to identify their size standard as concurred in by the Small Business Administration. The Government requests that no proprietary or confidential business data be submitted in a response to this notice. However, should a respondent wish to include proprietary information, that information should be clearly marked and the Government will properly safeguard it. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market research that do not provide sufficient information will not be considered. When submitting this information, reference the sources sought notice number identified herein. Capability statements shall only be submitted electronically (i.e. via e-mail) to the point of contact listed below, in either MS-Word or Adobe Portable Document Format (PDF), no later than JAN/04/2013. Late responses will not be considered. This notice does not obligate the Government to award a contract nor to pay for the information provided in responses. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate, including the use of non-proprietary technical information in any resultant solicitation. Organizations responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or to provide feedback to respondents with respect to any information submitted. After the Government's review of responses, pre-solicitation and solicitation notices may be published on the Federal Business Opportunities website. Responses to this notice shall not be considered adequate responses to a solicitation. A solicitation release date is pending the results of this notice. The Government intends to award one (1) contract for a period of five (5) years on or about October, 2013. Point of Contact Ms. Patty Hanacek, Contract Specialist, Contracts Management Branch, NIAAA, phone 301-594-6226, [hanacekp@mail.nih.gov] This notice is issued on behalf of the NIAAA by the National Institute of Child Health and Human Development, Office of Acquisitions, NIH, DHHS, UNITED STATES
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